FDA Developing Rules on Compounded Medications
Mike Jawer, AANP Director of Government and Public Affairs
Tuesday, June 24, 2014
by: Mike Jawer, AANP Director of Government and Public Affairs

Section: State and Federal Advocacy

The Food and Drug Administration (FDA), after a raft of comments submitted by AANP and numerous other organizations across the country, is holding a meeting of stakeholders to weigh concerns regarding the agency’s development of regulations implementing the Drug Quality and Security Act. AANP will be part of those discussions, as will the association representing compounding pharmacists.
Meanwhile, some Members of Congress are putting the FDA on notice that they expect the agency’s proposed guidance to continue allowing for “office use,” i.e., physicians’ ability to administer safely compounded medications (such as injectables and IV solutions) to patients in the office. Representatives Morgan Griffith (R-VA), Diana DeGette (D-CO) and Gene Green (D-TX) have drafted a letter to FDA Commissioner Margaret Hamburg, and additional signators are being sought.
If you’re an ND in a licensed state, please encourage your Representative to sign this letter right away. Instructions are here.
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